FDA Enforcement
Class II
Terminated
Juggerknotless Drill Bit, REF 110003173, Sterile, Single Use Product Usage: The Juggerknotless Soft Anchors are indicated for soft tissue reattachment procedures in the shoulder, foot/ankle, hand/wrist, and hip.
Recall: Z-0364-2014
·
Reported November 27, 2013
Enforcement
- Recall Number
- Z-0364-2014
- Event ID
- 66639
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Biomet, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 27, 2013
- Initiation Date
- October 10, 2013
- Classification Date
- November 19, 2013
- Termination Date
- July 16, 2014
- Address
- 56 E Bell Dr, Warsaw, IN, 46582-6989, United States
Description
Juggerknotless Drill Bit, REF 110003173, Sterile, Single Use Product Usage: The Juggerknotless Soft Anchors are indicated for soft tissue reattachment procedures in the shoulder, foot/ankle, hand/wrist, and hip.
Reason
Investigation identified that the design of the drill bit may make the suture anchor difficult to insert into the bone. The implant may skip across the hole or miss the hole during insertion.
Code Info
Catalog:110003173, Lot 127480, 185420, 233500, 233520
Distribution
USA Nationwide Distribution in the states of VA, CA, Ky, and IN
Quantity
25